Multiple ibuprofen products recalled for improper storage temperature
Family Dollar is recalling multiple ibuprofen products, including MOTRIN and GOOD SENSE brands, due to improper storage temperature conditions at distribution facilities from April through June 2022.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for CGMP deviations involving improper storage temperature. No illnesses or injuries reported in the source. The hazard is precautionary, relating to manufacturing and handling control rather than confirmed product failure.
Plain-English summary
Family Dollar Stores, LLC is recalling multiple ibuprofen-containing products that were distributed to Family Dollar Stores nationwide between April 30, 2022, and June 10, 2022. The products were held outside appropriate storage temperature conditions, which constitutes a deviation from Current Good Manufacturing Practice (CGMP) standards.
The affected products include MOTRIN IB CAPLETS (24 ct, SKU 999394), GOOD SENSE IBUPROFEN 200MG TABLETS (24 ct, SKU 900556), GOOD SENSE IBUPROFEN 200MG CAPLETS (50 ct, SKU 902333), MOTRIN CHILDREN'S BUBBLEGUM (4 fl oz, SKU 903048), GOOD SENSE IBUPROFEN REGULAR SOFTGELS (160 ct, SKU 999373), GOOD SENSE IBUPROFEN 200MG CAPLETS (100 ct, SKU 902359), MOTRIN IB CAPLETS (50 ct, SKU 900604), GOOD SENSE IBUPROFEN IB CAPLETS (100 ct, SKU 913989), GOOD SENSE IBUPROFEN 200MG SOFTGELS (20 ct, SKU 916994), ADVIL LIQUID GEL (40 ct, SKU 916071), GOOD SENSE IBUPROFEN PM 200MG (20 ct, SKU 917004), ADVIL PM CAPLETS (20 ct, SKU 913010), and GOOD SENSE IBUPROFEN TABLETS (100 ct, SKU 913991).
The recalled product
- Product
- MOTRIN IB CAPLETS 24CT SKU999394; GOOD SENSE IBUPROFEN 200MG TABLETS 24CT SKU 900556;GOOD SENSE IBUPROFEN 200MG CAPLET 50 CT SKU 902333 MOTRIN CHILDREN'S BUBBLEGUM 4 FL OZ SKU 903048 GOOD SENSE IBUPROFEN REGULAR SOFTGELS 160CT SKU 999373 GOOD SENSE IBUPROFEN 200 MG…
- Manufacturer
- Family Dollar Stores, Llc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- SKUs: 999394
- 900556
- 902333
- 903048
- 999373
- 902359
- 900604 913989
- 916994
- 916071
- 917004
- 913010
- 913991
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by Family Dollar Stores, Llc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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